A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia

NCT ID: NCT02192723

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.

Detailed Description

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The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.

METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Typical antipsychotic

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day) for 8 weeks.

Group Type EXPERIMENTAL

Typical antipsychotic

Intervention Type DRUG

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day), twice per day, 8 weeks

Risperidone

Risperidone, 2\~6mg/day, twice day, 8 weeks

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

2\~6mg/day, twice per day, 8 weeks

Olanzapine

5\~20mg/day

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine, 400\~750mg/day, twice per day, 8 weeks

Quetiapine

400\~750mg/day

Group Type ACTIVE_COMPARATOR

Quetiapine

Intervention Type DRUG

Quetiapine, 400~750mg/day, twice per day, 8 weeks

Aripiprazole

Aripiprazole, 10\~30mg/day, twice per day, 8 weeks

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DEVICE

Aripiprazole, 10~30mg/day, twice per day, 8 weeks

Ziprasidone

Ziprasidone, 80\~160mg/day, twice per day, 8 weeks

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

Ziprasidone 80\~160mg/day, twice per day, 8 weeks

Interventions

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Typical antipsychotic

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day), twice per day, 8 weeks

Intervention Type DRUG

Risperidone

2\~6mg/day, twice per day, 8 weeks

Intervention Type DRUG

Olanzapine

Olanzapine, 400\~750mg/day, twice per day, 8 weeks

Intervention Type DRUG

Quetiapine

Quetiapine, 400~750mg/day, twice per day, 8 weeks

Intervention Type DRUG

Aripiprazole

Aripiprazole, 10~30mg/day, twice per day, 8 weeks

Intervention Type DEVICE

Ziprasidone

Ziprasidone 80\~160mg/day, twice per day, 8 weeks

Intervention Type DRUG

Other Intervention Names

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Haldol and Trilafon Risperdal Zyprexa Seroquel Abilify Geodon

Eligibility Criteria

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Inclusion Criteria

* Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
* Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
* A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.

Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing HuiLongGuan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiang Yang Zhang

Director, the Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhi-Ren Wang, MD, PhD

Role: STUDY_DIRECTOR

Beijing HuiLongGuan Hospital

Locations

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Beijing HuiLongGuan Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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Project863

Identifier Type: -

Identifier Source: org_study_id

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